Pancreatic AdenocarcinomaPhase 1DECISTNCT04157127
Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma
A Phase 1 study testing Autologous DC Therapy in people with Pancreatic Adenocarcinoma and Pancreatic Cancer, run by Diakonos Oncology Corporation at 3 sites in United States.
Trial summary
This is a phase 1, first in human, dose escalation study for safety and feasibility of multi-dose dendritic cell (DC) therapy for pancreatic ductal adenocarcinoma (PDAC) including adenosquamous carcinoma administered after surgical resection of PDAC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma, Pancreatic Cancer, Pancreatic Adenosquamous Carcinoma
- What is being tested?
- Autologous DC Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Aug 2020to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Male or female, aged 18 years and older
- Cytological or pathological confirmation of adenocarcinoma or adenosquamous carcinoma of the pancreas is deemed to be potentially resectable or borderline resectable based on tumor and host factors. This may include patients who undergo upfront resection or those who receive neoadjuvant chemotherapy +/- radiation prior to resection.
- Adequate kidney, liver, bone marrow function, and immune function, as follows, within 28 days prior to registration:
- Hemoglobin ≥ 8.0 gm/dL
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- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- Platelet count ≥ 75,000 /mm3
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN),
- Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 2.5 times the ULN
- ECOG performance status ≤ 2.
- For women of childbearing potential (WOCBP): use of highly effective contraception must be discussed with participants. NOTE: Patient must agree to start contraception at least 30 days before first vaccination and continue for at least 12 weeks after her last vaccination.
- WOCBP must have a negative serum pregnancy prior to vaccination
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 12 weeks following discontinuations of last vaccination.
- Patient must agree to not donate blood for up to 90 days after last vaccination.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unresectable or metastatic (stage IV) pancreatic cancer.
- Patients with known HIV and a positive viral load.
- Patients with active HBV and HCV infection. Those who are Hepatitis B sAb positive as well as those who are Hepatitis C Ab positive, but Hepatitis C RNA viral load negative will not be excluded.
- Patients with any active autoimmune disease or immune deficiency or previous Guillain-Barre syndrome. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g. patient with psoriatic arthritis are excluded) are eligible provided all of the following conditions are met:
- Rash that covers less than 10 % of body surface area.
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- Disease is well controlled at baseline and requires only low-potency topical corticosteroids.
- No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.
- Use of nonstandard neoadjuvant chemotherapy regimen, as determined by the Investigator.
- Female patients who are pregnant, breastfeeding, or of childbearing potential without a negative pregnancy test within 28 days (or decline contraception requirements as outlined above). Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Patients unwilling or unable to comply with the protocol or provide informed consent.
- Any severe or uncontrolled medical condition or other condition that could affect participation in this study (in the opinion of the investigator), including but not limited to hyper/hypothyroidism, active systemic autoimmune disorders, untreated viral hepatitis or autoimmune hepatitis.
- Requires chronic treatment with a systemic steroid (⩾10 mg/day of prednisone equivalent) or with any systemic immunosuppressive agent.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Baylor College of Medicine Medical Center - McNair Campus
Houston, Texas, 77030
Benjamin Musher, MD, 713-798-4292, blmusher@bcm.edu
- Recruiting
Baylor St. Lukes Medical Center
Houston, Texas, 77030
Benjamin Musher, 713-798-4292, blmusher@bcm.edu
- Recruiting
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, 77030
Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor, 713-798-1297
About this study
Official title: Phase I Study of Th-1 Dendritic Cell Immunotherapy in Combination With Standard Chemotherapy for the Adjuvant Treatment of Pancreatic Adenocarcinoma (DECIST)
This is a phase 1, first in human, dose escalation study for safety and feasibility of multi-dose dendritic cell (DC) therapy for pancreatic ductal adenocarcinoma (PDAC) including adenosquamous carcinoma administered after surgical resection of PDAC.
Read the detailed description
The primary objective of this phase 1, first in human trial is to determine the safety, toxicity, and feasibility of delivering autologous DCs loaded with pancreatic adenocarcinoma lysate and mRNA to pancreatic cancer patients following surgery.
After having undergone surgical resection of their PDAC (with or without prior neoadjuvant chemotherapy), patients will undergo apheresis for the manufacture of the DC therapy. Once the DC therapy has been manufactured, it will be administered by image-guided injections proximal to a lymph node near the surgical bed with concurrent use of subcutaneous peg-IFN. Patients will have the option to receive additional doses of the DC therapy and peg-IFN if they are eligible and interested.
- Being tested
- Autologous DC Therapy
- Keywords
- Immunotherapy, Adjuvant therapy, Cell Therapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous DC TherapyBiological
Autologous DC Therapy
| Study group | Role | What they receive |
|---|---|---|
| Autologous DC Therapy Group B Cohort 1 | Experimental | The DC therapy is manufactured from autologous dendritic cells loaded with tumor cell lysate and RNA. Patients will receive 2 doses of DC therapy (separated by 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During intervention, patients receive weekly peg-IFN at 180 mcg/week on the first day of administration up through 14 days after last dose.
DC Therapy dose evaluated in Group B Cohort 1:
First Cycle 1st dose - 8 million cells First Cycle 2nd dose - 8 million cells Second Cycle 1st dose - 8 million cells (optional) Second Cycle 2nd dose - 8 million cells (optional)
Patients in Group B cohort 1 will receive the DC therapy after neoadjuvant chemotherapy and surgery (1st cycle), with an option for additional DC therapy (2nd cycle) after adjuvant chemotherapy. Receives: Biological: Autologous DC Therapy |
| Autologous DC Therapy Group B Cohort 2 | Experimental | The DC therapy is manufactured from autologous dendritic cells loaded with tumor cell lysate and RNA. Patients will receive 2 doses of DC therapy (separated by 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During intervention, patients receive weekly peg-IFN at 180 mcg/week on the first day of administration up through 14 days after last dose.
DC Therapy dose evaluated in Group B Cohort 2:
First Cycle 1st dose - 12 million cells First Cycle 2nd dose - 12 million cells Second Cycle 1st dose - 12 million cells (optional) Second Cycle 2nd dose - 12 million cells (optional)
Patients in Group B cohort 2 will receive the DC therapy after neoadjuvant chemotherapy and surgery (1st cycle), with an option for additional DC therapy (2nd cycle) after adjuvant chemotherapy. Receives: Biological: Autologous DC Therapy |
| Autologous DC Therapy Group A | Experimental | ENROLLMENT IN THIS ARM HAS BEEN COMPLETED
The DC therapy is manufactured from autologous dendritic cells loaded with autologous tumor cell lysate and mRNA. Patients will receive 3 doses of DC therapy (one every 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During intervention, patients receive weekly peg-IFN at 180 mcg/week on the first day of administration up through 14 days after last dose.
DC Therapy dose evaluated in Group A:
1. st dose - 0.5 million cells
2. nd dose - 1 million cells
3. rd dose - 2 million cells
Patients in Group A will receive the DC therapy after neoadjuvant chemotherapy, surgery and adjuvant chemotherapy. Receives: Biological: Autologous DC Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of DC Therapy
To determine the safety (measured by the frequency/duration of adverse events as defined by the Common Terminology Criteria for Adverse Events Version 5.0) and feasibility of delivering autologous dendritic cells loaded with pancreatic adenocarcinoma lysate and mRNA after surgical resection (evaluated by the ease of administering the study drug product proximal to a lymph node near the surgical bed).
Measured: From treatment start until 6 weeks after.
Number of participants who experienced Dose Limiting Toxicities (DLTs)
A DLT is defined as any non-hematologic toxicity of grade 3 or 4 by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0) that was probably or definitely DC-therapy related. Certain grade 4 hematologic toxicities that are probably or definitely DC-therapy related are also considered DLTs. Grade 2 or 3 myelosuppression that does not resolve or recover (with supportive measures) to grade 1 within 2 weeks that is probably or definitely DC-vaccine related is also considered a DLT. Grade 2 non-hematologic toxicities that do not resolve or recover (with supportive measures) to grade 1 within 2 weeks that are probably or definitely DC-therapy related are also considered DLTs. Any toxicity, regardless of grade, where systemic steroids are used as supportive care for management that is probably or definitely DC-therapy related is also considered a DLT.
Measured: From treatment start until 6 weeks after.
Secondary outcomes (2)
Recurrence-Free Survival
Measurement of time from resection surgery to recurrence of pancreatic adenocarcinoma.
Measured: From surgery until recurrence or up to 3 years after surgery, whichever comes first.
Overall Survival
Measurement of time from resection surgery to death.
Measured: From surgery until death or up to 3 years after surgery, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start3 Aug 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a single-arm, open-label study where all subjects will receive the DC therapy. The number of cells administered will vary based on the group/cohort determination. Group A receives intervention after neoadjuvant chemotherapy, surgery and adjuvant chemotherapy. Group B contains 2 cohorts (low and high dose) with intervention (1st cycle) after surgery, but before adjuvant chemotherapy with the option for intervention after adjuvant chemotherapy (2nd cycle).
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakonos Oncology Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- Benjamin Musher, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157127
- Sponsor's protocol ID
- H-42434
- Acronym
- DECIST
- Status last verified
- Aug 2026
- First submitted
- 6 Nov 2019
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Th-1 Dendritic Cell Immunotherapy in Combination With Standard Chemotherapy for the Adjuvant Treatment of Pancreatic Adenocarcinoma (DECIST)
- ClinicalTrials.gov ID
- NCT04157127
- Acronym / sponsor ID
- DECIST / H-42434
- Keywords
- Immunotherapy, Adjuvant therapy, Cell Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Diakonos Oncology CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Baylor College of Medicine
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1, first in human, dose escalation study for safety and feasibility of multi-dose dendritic cell (DC) therapy for pancreatic ductal adenocarcinoma (PDAC) including adenosquamous carcinoma administered after surgical resection of PDAC.
Detailed description
The primary objective of this phase 1, first in human trial is to determine the safety, toxicity, and feasibility of delivering autologous DCs loaded with pancreatic adenocarcinoma lysate and mRNA to pancreatic cancer patients following surgery.
After having undergone surgical resection of their PDAC (with or without prior neoadjuvant chemotherapy), patients will undergo apheresis for the manufacture of the DC therapy. Once the DC therapy has been manufactured, it will be administered by image-guided injections proximal to a lymph node near the surgical bed with concurrent use of subcutaneous peg-IFN. Patients will have the option to receive additional doses of the DC therapy and peg-IFN if they are eligible and interested.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a single-arm, open-label study where all subjects will receive the DC therapy. The number of cells administered will vary based on the group/cohort determination. Group A receives intervention after neoadjuvant chemotherapy, surgery and adjuvant chemotherapy. Group B contains 2 cohorts (low and high dose) with intervention (1st cycle) after surgery, but before adjuvant chemotherapy with the option for intervention after adjuvant chemotherapy (2nd cycle).
| Arm | Type | Receives |
|---|---|---|
| Autologous DC Therapy Group B Cohort 1 | Experimental | Biological: Autologous DC TherapyThe DC therapy is manufactured from autologous dendritic cells loaded with tumor cell lysate and RNA. Patients will receive 2 doses of DC therapy (separated by 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During intervention, patients receive weekly peg-IFN at 180 mcg/week on the first day of administration up through 14 days after last dose. DC Therapy dose evaluated in Group B Cohort 1: First Cycle 1st dose - 8 million cells First Cycle 2nd dose - 8 million cells Second Cycle 1st dose - 8 million cells (optional) Second Cycle 2nd dose - 8 million cells (optional) Patients in Group B cohort 1 will receive the DC therapy after neoadjuvant chemotherapy and surgery (1st cycle), with an option for additional DC therapy (2nd cycle) after adjuvant chemotherapy. |
| Autologous DC Therapy Group B Cohort 2 | Experimental | Biological: Autologous DC TherapyThe DC therapy is manufactured from autologous dendritic cells loaded with tumor cell lysate and RNA. Patients will receive 2 doses of DC therapy (separated by 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During intervention, patients receive weekly peg-IFN at 180 mcg/week on the first day of administration up through 14 days after last dose. DC Therapy dose evaluated in Group B Cohort 2: First Cycle 1st dose - 12 million cells First Cycle 2nd dose - 12 million cells Second Cycle 1st dose - 12 million cells (optional) Second Cycle 2nd dose - 12 million cells (optional) Patients in Group B cohort 2 will receive the DC therapy after neoadjuvant chemotherapy and surgery (1st cycle), with an option for additional DC therapy (2nd cycle) after adjuvant chemotherapy. |
| Autologous DC Therapy Group A | Experimental | Biological: Autologous DC TherapyENROLLMENT IN THIS ARM HAS BEEN COMPLETED The DC therapy is manufactured from autologous dendritic cells loaded with autologous tumor cell lysate and mRNA. Patients will receive 3 doses of DC therapy (one every 14 days) and be monitored (vital signs every 30 minutes) for 2 hours after each dose. During intervention, patients receive weekly peg-IFN at 180 mcg/week on the first day of administration up through 14 days after last dose. DC Therapy dose evaluated in Group A: 1. st dose - 0.5 million cells 2. nd dose - 1 million cells 3. rd dose - 2 million cells Patients in Group A will receive the DC therapy after neoadjuvant chemotherapy, surgery and adjuvant chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Provision of signed and dated informed consent form
- Male or female, aged 18 years and older
- Cytological or pathological confirmation of adenocarcinoma or adenosquamous carcinoma of the pancreas is deemed to be potentially resectable or borderline resectable based on tumor and host factors. This may include patients who undergo upfront resection or those who receive neoadjuvant chemotherapy +/- radiation prior to resection.
- Adequate kidney, liver, bone marrow function, and immune function, as follows, within 28 days prior to registration:
- ECOG performance status ≤ 2.
Key exclusion criteria (13 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unresectable or metastatic (stage IV) pancreatic cancer.
- Patients with known HIV and a positive viral load.
- Patients with active HBV and HCV infection. Those who are Hepatitis B sAb positive as well as those who are Hepatitis C Ab positive, but Hepatitis C RNA viral load negative will not be excluded.
- Patients with any active autoimmune disease or immune deficiency or previous Guillain-Barre syndrome. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g. patient with psoriatic arthritis are excluded) are eligible provided all of the following conditions are met:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous DC TherapyAutologous DC Therapy | Biological | Autologous DC Therapy Group A, Autologous DC Therapy Group B Cohort 1, Autologous DC Therapy Group B Cohort 2 |
Primary outcome
Safety of DC Therapy
Time frame: From treatment start until 6 weeks after.
To determine the safety (measured by the frequency/duration of adverse events as defined by the Common Terminology Criteria for Adverse Events Version 5.0) and feasibility of delivering autologous dendritic cells loaded with pancreatic adenocarcinoma lysate and mRNA after surgical resection (evaluated by the ease of administering the study drug product proximal to a lymph node near the surgical bed).
Number of participants who experienced Dose Limiting Toxicities (DLTs)
Time frame: From treatment start until 6 weeks after.
A DLT is defined as any non-hematologic toxicity of grade 3 or 4 by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0) that was probably or definitely DC-therapy related. Certain grade 4 hematologic toxicities that are probably or definitely DC-therapy related are also considered DLTs. Grade 2 or 3 myelosuppression that does not resolve or recover (with supportive measures) to grade 1 within 2 weeks that is probably or definitely DC-vaccine related is also considered a DLT. Grade 2 non-hematologic toxicities that do not resolve or recover (with supportive measures) to grade 1 within 2 weeks that are probably or definitely DC-therapy related are also considered DLTs. Any toxicity, regardless of grade, where systemic steroids are used as supportive care for management that is probably or definitely DC-therapy related is also considered a DLT.
2 secondary outcomes
Recurrence-Free Survival
Time frame: From surgery until recurrence or up to 3 years after surgery, whichever comes first.
Overall Survival
Time frame: From surgery until death or up to 3 years after surgery, whichever comes first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Musher, MD principal investigator
Baylor College of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous DC Therapy in people with Pancreatic Adenocarcinoma and Pancreatic Cancer, run by Diakonos Oncology Corporation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Musher, MD (713-798-4292, blmusher@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of DC Therapy (time frame: From treatment start until 6 weeks after.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.